No registrations found.
ID
Source
Brief title
Health condition
1. Unexplained subfertility for at least one year
2. Chance on a spontaneous pregnancy of ≥ 30% calculated by the model of Hunault
3. An advice for expectant management for at least 6 months
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ongoing pregnancy, naturally conceived within six months after randomization
Secondary outcome
1. Time to pregnancy
2. Mean change in sexual activity
3. Mean change in each partners’ sexual functioning
4. Mean change in individual wellbeing of each partner
5. Time and interactive effects on all outcomes
Background summary
Each year, 5,000 heterosexual couples are diagnosed with unexplained subfertility and a good prognosis (≥ 30% chance on a live-bornchild after natural conception within 12 months). The guidelines of the DutchSociety of Obstetrics and Gynaecology (NVOG) currently advise postponing medically assisted reproduction(MAR) for six months in these couples as this is equally effective as sixmonths of intra-uterine insemination (IUI) with controlled ovarian stimulation. Until now, expectant management simply means sending couples home for continuing to attempt natural conception without guidance on sexual activity,surveillance or support.
Expectant management proves to be challenging in clinical practice because of pressure from desperate couples who have a lack of confidence in natural conception and who overestimate success rates of MAR.
According to a small cohort study, sex counselling can increase the proportion of couples having intercourse during their fertile days and can thereby increase ongoing pregnancy rates. Whether sex counselling indeed increases ongoing pregnancy rates, however, has never been demonstrated in a randomized clinical trial.
Objective
To compare the effectiveness, expressed in terms of naturally conceived ongoing pregnancy rate, and the cost-effectiveness of six months of internet-based sex counseling to six months of expectant management without guidance on sexual activity, surveillance or support in couples with unexplained subfertility and a good prognosis.
Study objective
Online sex-counseling improves the probability of a naturally conceived pregnancy in heterosexual couples with unexplained subfertility and a good prognosis
Study design
Ongoing pregnancy, naturally conceived within six months after randomization
Intervention
Six months of internet-based sex counselling aiming to increase the probability of natural conception of an ongoing pregnancy
P.O. Box 22660
I. Custers
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5664355 or +31 (0)20 5669111
i.m.custers@amc.uva.nl
P.O. Box 22660
I. Custers
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5664355 or +31 (0)20 5669111
i.m.custers@amc.uva.nl
Inclusion criteria
1. Heterosexual couples with unexplained subfertility
2. ≥ 30% chance of an naturally conceived ongoing pregnancy calculated (Hunault)
3. Sufficient command of the Dutch language
Exclusion criteria
1. Somatic or psychological problems interfering with the couples ability to have sexual intercourse
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL4467 |
NTR-old | NTR5709 |
Other | METC AMC (Amsterdam) NL55012.018.15 : ZonMW 843001605 |